Polymer Technology Systems

Matched from indexed company URL: POLYMER TECHNOLOGY CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155251483002698769Polymer Technology Systems1N2026-01-014600 Anson Boulevard Whitestown IN US 46075
18361353002698769POLYMER TECHNOLOGY SYSTEMS, INC.1N2020-04-257736 Zionsville Rd INDIANAPOLIS IN US 46268
29543613002940409POLYMER TECHNOLOGY SYSTEMS, INC.1N2020-04-25510 Oakmead Pkwy SUNNYVALE CA US 94085

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00381930737014A1CNow+ Controls™ Levels 1+2 - The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. The control consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the A1CNow system. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.+1(888)877-5610customerservice@ptsdiagnostics.com
00381931716018PTS Panels® Triglycerides Test Strips - PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.+1(888)870-5610customerservice@ptsdiagnostics.com
00381931716018PTS Panels® Triglycerides Test Strips - PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.+1(888)877-5610customerservice@ptsdiagnostics.com
00381931716018PTS Panels® Triglycerides Test Strips - PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.+1(877)870-5610customerservice@ptsdiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2301272004244853K993096PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITORCHH1999-12-20
537262004244853K993096PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITORCHH1999-12-20
537261285450771K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSJGY2000-05-24
2301271285450771K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSJGY2000-05-24
2301271427364015K990688MTM BIOSCANNER C TEST STRIPSCHH1999-06-24
537261427364015K990688MTM BIOSCANNER C TEST STRIPSCHH1999-06-24
537261625811542K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610JMK1999-12-27
2301271625811542K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610JMK1999-12-27
537261481318122K981865MTM BIOSCANNER K TEST STRIPSJMK1999-02-26
2301271481318122K981865MTM BIOSCANNER K TEST STRIPSJMK1999-02-26
537261094868855K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220CHH1998-07-22
2301271094868855K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220CHH1998-07-22
2301271707722418K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemNBW2022-02-26
537261182118671K182781PTS Professional Chemistry KitCGA2018-12-21
1674851182118671K182781PTS Professional Chemistry KitCGA2018-12-21
2301271182118671K182781PTS Professional Chemistry KitCGA2018-12-21
2301271648177097K162282CardioChek Plus Test System, CardioChek Home Test SystemCGA2016-12-22
537261648177097K162282CardioChek Plus Test System, CardioChek Home Test SystemCGA2016-12-22
2301271039697893K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemCHH2016-12-22
537261039697893K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemCHH2016-12-22
2301271969326083K151530CardioChek Plus Test SystemCGA2015-07-07
537261969326083K151530CardioChek Plus Test SystemCGA2015-07-07
537261276139235K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test SystemCGA2014-10-02
2301271276139235K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test SystemCGA2014-10-02
2301271918255599K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMNBW2015-05-22
537261918255599K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMNBW2015-05-22
537261312347491K103744DROPPER A1C DIABETES CONTROLJJX2011-05-12
2301271312347491K103744DROPPER A1C DIABETES CONTROLJJX2011-05-12
1674851312347491K103744DROPPER A1C DIABETES CONTROLJJX2011-05-12
1674851139366308K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECLCP2009-05-14
2301271139366308K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECLCP2009-05-14
537261336852717K071593PTS PANELS CHOL+HDL PANEL TEST STRIPSCHH2007-10-15
2301271336852717K071593PTS PANELS CHOL+HDL PANEL TEST STRIPSCHH2007-10-15
2301271691547492K071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPSNBW2007-09-10
537261691547492K071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPSNBW2007-09-10
537261741323664K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSNBW2007-01-31
2301271741323664K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSNBW2007-01-31
2301271439224948K060617PTS PANELS HDL CHOLESTEROL TEST STRIPSNAQ2006-04-05
537261439224948K060617PTS PANELS HDL CHOLESTEROL TEST STRIPSNAQ2006-04-05
2301271712469498K041750PTS PANELS CHOL+GLU TEST PANELNBW2004-07-23
537261712469498K041750PTS PANELS CHOL+GLU TEST PANELNBW2004-07-23
537261700899063K040693PTS PANELS LDL CHOLESTEROL TEST STRIPSMRR2004-07-06
2301271700899063K040693PTS PANELS LDL CHOLESTEROL TEST STRIPSMRR2004-07-06
537261941484892K033899LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITORNFX2004-05-20
2301271941484892K033899LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITORNFX2004-05-20
537261606525611K023558PTS PANELS LIPID PANEL TEST STRIPSCHH2002-11-15
2301271606525611K023558PTS PANELS LIPID PANEL TEST STRIPSCHH2002-11-15
537261165628272K022898PTS PANELS LIPID PANEL TEST STRIPSCHH2002-09-24
2301271165628272K022898PTS PANELS LIPID PANEL TEST STRIPSCHH2002-09-24
2301271377122529K022401PTS PANELS MULTI-CHEMISTRY CONTROLSJJY2002-08-21
537261377122529K022401PTS PANELS MULTI-CHEMISTRY CONTROLSJJY2002-08-21
2301271461113482K014099BIOSCANNER PLUSNBW2001-12-21
537261461113482K014099BIOSCANNER PLUSNBW2001-12-21
2301271083111825K013068BIOSCANNER 2000CGA2001-11-20
537261083111825K013068BIOSCANNER 2000CGA2001-11-20
2301271104304077K010456BIOSCANNER CREATININE TEST STRIPSJFY2001-06-20
537261104304077K010456BIOSCANNER CREATININE TEST STRIPSJFY2001-06-20
2301271105606720K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSJGY2000-07-03
537261105606720K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSJGY2000-07-03
2301271000627514
537261000627514
1674851000627514
2301271293161840
537261293161840
537261904219936
537261959102952
2301271904219936
2301271959102952

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHH152016-12-22
NBW112022-02-26
CGA112018-12-21
JGY42000-07-03
JMK41999-12-27
JJX32011-05-12
LCP22009-05-14
NAQ22006-04-05
MRR22004-07-06
NFX22004-05-20
JJY22002-08-21
JFY22001-06-20

PMA#

152 records. Showing 1-40. Next

PMN#

67 records. Showing 1-40. Next

GUDID#

75 records. Showing 1-40. Next